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Apellis Announces Mikael Dolsten, M.D., Ph.D., to Join Board of Directors
Globenewswire· 2026-03-02 12:00
Core Insights - Apellis Pharmaceuticals has appointed Dr. Mikael Dolsten to its board of directors, effective March 1, 2026, bringing over 16 years of experience from Pfizer where he oversaw the approval of more than 36 medicines and vaccines [1][2] Company Overview - Apellis Pharmaceuticals is a global biopharmaceutical company focused on complement science, developing therapies for serious diseases, including the first new class of complement medicine in 15 years [5] - The company has two C3-targeting medicines approved for treating four serious diseases, including the first therapy for geographic atrophy and the first treatment for patients aged 12 and older with C3G or primary IC-MPGN [5] Leadership and Expertise - Dr. Dolsten has held senior positions at various pharmaceutical companies, including Wyeth Pharmaceuticals, Boehringer Ingelheim, AstraZeneca, Pharmacia, and Upjohn, and currently serves on the boards of Agilent Technologies and Rocket Pharmaceuticals [2][3] - He has published approximately 160 scientific articles and book reviews and holds an M.D. and Ph.D. from Lund University in Sweden [4]
Apellis Pharmaceuticals Reports Fourth Quarter and Full Year 2025 Financial Results
Globenewswire· 2026-02-24 12:05
Core Insights - Apellis Pharmaceuticals reported its fourth quarter and full year 2025 financial results, highlighting significant progress and a strong foundation for future growth [1][2]. Financial Performance - Full-year 2025 net product revenues reached $689 million, with SYFOVRE generating $587 million and EMPAVELI contributing $102 million [6][10]. - Total revenue for Q4 2025 was $199.9 million, compared to $212.5 million in Q4 2024, while total revenue for the full year was $1.0 billion, up from $781.4 million in 2024 [9][10]. - The company reported a net loss of $58.9 million for Q4 2025, compared to a net loss of $36.4 million in Q4 2024, but achieved a net income of $22.4 million for the full year, a significant improvement from a net loss of $197.9 million in 2024 [10][11]. Product Highlights - SYFOVRE, the first approved therapy for geographic atrophy (GA), maintained a market share of approximately 60% and delivered around 102,000 doses in Q4 2025 [7][14]. - EMPAVELI showed strong momentum with a successful launch in C3 glomerulopathy (C3G) and primary immune complex glomerulonephritis (IC-MPGN), achieving over 5% penetration of the U.S. patient population [7][15]. - A regulatory submission for a prefilled syringe of SYFOVRE is planned for the first half of 2026, and pivotal trials for EMPAVELI in focal segmental glomerulosclerosis (FSGS) and delayed graft function (DGF) are underway [6][7]. Research and Development - The company is advancing its pipeline, including a Phase 2 study of SYFOVRE combined with APL-3007, with topline data expected in 2027 [7][8]. - Apellis is also progressing pre-clinical research on APL-9099, a potential one-time treatment using base editing technology, with an IND submission planned for the second half of 2026 [8]. Cash Position - As of December 31, 2025, Apellis had cash and cash equivalents of $466 million, an increase from $411 million in 2024, and expects this to be sufficient to fund operations to profitability [11][12].
Apellis Pharmaceuticals (NASDAQ: APLS) Earnings Preview and Financial Health
Financial Modeling Prep· 2026-02-23 18:00
Core Viewpoint - Apellis Pharmaceuticals is a biopharmaceutical company focused on complement science, developing innovative therapies for serious diseases, with two approved C3-targeting medicines [1] Financial Performance - Apellis is set to release its quarterly earnings on February 24, 2026, with Wall Street estimating an earnings per share (EPS) of -$0.39 and analysts predicting a slightly larger loss of -$0.41 per share [2][6] - Revenue projections are estimated at $199.4 million by Wall Street and $199 million by analysts [2] - The current stock price is $22.28, reflecting a 2.3% decrease, with a market capitalization of $2.82 billion and a price-to-earnings (P/E) ratio of 71.87 [3][6] Stock Performance - Over the past year, APLS stock has fluctuated between a low of $16.10 and a high of $30.48 [3] - The fifty-day simple moving average is $23.31, while the two-hundred-day simple moving average is $23.87 [3] Financial Ratios - The company maintains a quick ratio of 3.10 and a current ratio of 3.54, indicating strong liquidity [4][6] - The debt-to-equity ratio is 0.90, showing moderate financial leverage [4][6] - The price-to-sales ratio is 2.77, and the enterprise value to sales ratio is also 2.77, reflecting its market value compared to sales [4] Market Expectations - The upcoming earnings report is crucial for APLS as it could influence the stock's near-term price movement, with potential upward trends if results exceed expectations [5] - The sustainability of any immediate price changes will depend on management's discussion during the earnings call [5]
Apellis Pharmaceuticals to Present at the TD Cowen 46th Annual Health Care Conference
Globenewswire· 2026-02-23 12:00
Company Overview - Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company focused on complement science to develop therapies for challenging diseases [2] - The company has introduced the first new class of complement medicine in 15 years, with two C3-targeting medicines approved for four serious diseases [2] - Notable breakthroughs include the first therapy for geographic atrophy, a leading cause of blindness, and the first treatment for patients aged 12 and older with C3G or primary IC-MPGN, both severe and rare kidney diseases [2] - Apellis believes it has only begun to unlock the potential of targeting C3 across various serious diseases [2] Upcoming Events - The company will participate in a webcast fireside chat at the TD Cowen 46th Annual Health Care Conference on March 2, 2026, at 9:50 a.m. ET [1] - The live conference webcast will be available on the company's website, with a replay accessible for approximately 30 days following the event [1]
Apellis Announces Eight Oral Presentations at the 49th Macula Society Annual Meeting
Globenewswire· 2026-02-19 12:00
Core Insights - Apellis Pharmaceuticals will present five-year results from the GALE study, highlighting the significant impact of early and continuous treatment with SYFOVRE (pegcetacoplan injection) for patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) [1][2][3] Group 1: Study Details - The GALE study is a Phase 3, multicenter, open-label extension study involving 792 participants, aimed at evaluating the long-term safety and efficacy of SYFOVRE in patients with GA secondary to AMD [4] - The study's objectives include assessing the long-term incidence and severity of treatment-emergent adverse events and measuring changes in the total area of GA lesions using fundus autofluorescence [4] - More than 80% of participants from the OAKS and DERBY studies transitioned into the GALE study [4] Group 2: Treatment Efficacy - The five-year results from the GALE study will demonstrate the importance of early treatment with SYFOVRE in preserving retinal tissue and delaying disease progression in GA patients [3] - The oral presentation titled "Earlier Treatment Yields Better Outcomes: 5-Years of Pegcetacoplan Treatment for Geographic Atrophy Secondary to AMD" is scheduled for February 27 [3] - In the OAKS and DERBY studies, SYFOVRE showed a reduction in GA lesion growth at 24 months, with increasing effects over time and a well-demonstrated safety profile [8][7] Group 3: Background on Geographic Atrophy - Geographic atrophy is an advanced form of AMD and a leading cause of blindness, affecting over one million Americans and five million people globally [10] - The disease is characterized by the growth of lesions that destroy retinal cells responsible for vision, leading to significant impairment in quality of life [10] - On average, GA lesions begin to impact the fovea, responsible for central vision, within 2.5 years [10] Group 4: Company Overview - Apellis Pharmaceuticals is a global biopharmaceutical company focused on developing therapies targeting the complement system for serious diseases [15] - The company has introduced the first-ever therapy for geographic atrophy and has two C3-targeting medicines approved for severe, rare kidney diseases [15] - Apellis aims to unlock the potential of targeting C3 across various serious diseases [15]
Apellis Pharmaceuticals to Host Conference Call on February 24, 2026, to Discuss Fourth Quarter and Full Year 2025 Financial Results
Globenewswire· 2026-02-10 12:00
Core Viewpoint - Apellis Pharmaceuticals, Inc. will host a conference call and webcast to discuss its fourth quarter and full year 2025 financial results on February 24, 2026 at 8:30 a.m. ET [1] Company Overview - Apellis Pharmaceuticals is a global biopharmaceutical company focused on complement science, developing therapies for challenging diseases [3] - The company has introduced the first new class of complement medicine in 15 years, with two C3-targeting medicines approved for four serious diseases [3] - Notable breakthroughs include the first therapy for geographic atrophy, a leading cause of blindness, and the first treatment for patients aged 12 and older with C3G or primary IC-MPGN, both severe and rare kidney diseases [3] - The company believes it has only begun to unlock the potential of targeting C3 across various serious diseases [3]
Apellis Highlights Commercial Execution and Strategic Priorities at the 44th Annual J.P. Morgan Healthcare Conference
Globenewswire· 2026-01-12 12:00
Core Insights - Apellis Pharmaceuticals reported preliminary U.S. net product revenues of approximately $689 million for the full year 2025, with a strong focus on expanding its product offerings and market presence in 2026 [6][9][10]. Financial Performance - The company achieved approximately $155 million in U.S. net product revenues for the fourth quarter of 2025 and $587 million for the full year [17]. - Preliminary year-end cash and cash equivalents stood at approximately $466 million, which is expected to be sufficient to fund operations to profitability [10]. Product Development and Market Position - SYFOVRE (pegcetacoplan injection) demonstrated a 17% year-over-year growth in total injection demand, maintaining a market share of approximately 60% in the geographic atrophy (GA) market [6][7]. - EMPAVELI (pegcetacoplan) has achieved over 5% market penetration in C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) following its first full quarter post-launch, with 267 new patient start forms received [6][7]. - The company plans to submit a regulatory application for a prefilled syringe of SYFOVRE in the first half of 2026 [6][7]. Strategic Initiatives - Apellis aims to expand its geographic atrophy market and strengthen SYFOVRE's competitive position through targeted initiatives [2]. - The company is advancing its pipeline, including pivotal trials for EMPAVELI in additional nephrology indications such as focal segmental glomerulosclerosis (FSGS) and delayed graft function (DGF) [6][7]. Collaborations and Partnerships - Apellis has a collaboration with Sobi for the global co-development of systemic pegcetacoplan, with Sobi holding exclusive ex-U.S. commercialization rights [14].
Apellis Pharmaceuticals to Present at the 44th Annual J.P. Morgan Healthcare Conference
Globenewswire· 2026-01-05 12:00
Company Overview - Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company focused on complement science to develop therapies for challenging diseases [2] - The company has introduced the first new class of complement medicine in 15 years, with two C3-targeting medicines approved for four serious diseases [2] - Notable breakthroughs include the first therapy for geographic atrophy, a leading cause of blindness, and the first treatment for patients aged 12 and older with C3G or primary IC-MPGN, both severe and rare kidney diseases [2] Upcoming Events - Apellis Pharmaceuticals will present at the 44th Annual J.P. Morgan Healthcare Conference on January 12, 2026, at 11:15 a.m. PT [1] - A live conference webcast will be available on the company's website, with a replay accessible for approximately 90 days post-event [1]
The New England Journal of Medicine Publishes Positive Phase 3 VALIANT Results of EMPAVELI® (pegcetacoplan) for C3G and Primary IC-MPGN
Globenewswire· 2025-12-03 22:05
Core Insights - Apellis Pharmaceuticals announced positive results from the Phase 3 VALIANT study for EMPAVELI (pegcetacoplan) in treating C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN), rare kidney diseases [1][4] Company Overview - Apellis Pharmaceuticals is a biopharmaceutical company focused on complement science, developing therapies for serious diseases, including the first treatment for C3G and primary IC-MPGN in patients aged 12 and older [25] Study Results - The VALIANT study demonstrated a statistically significant 68% reduction in proteinuria in EMPAVELI-treated patients compared to placebo [7] - EMPAVELI-treated patients showed stabilization of kidney function with a difference of +6.3 mL/min/1.73 m compared to placebo [7] - A majority of EMPAVELI-treated patients achieved zero C3 staining intensity, indicating complete clearance of C3 deposits [7][6] Safety Profile - The VALIANT study reported favorable safety and tolerability for EMPAVELI, with common adverse reactions including infusion site reactions, pyrexia, and nasopharyngitis [3][22] - No cases of meningococcal infection due to encapsulated bacteria were reported across over 2,750 patient-years of experience with EMPAVELI [3] Market Potential - Approximately 50% of patients with C3G and primary IC-MPGN may experience kidney failure within five to ten years of diagnosis, highlighting the urgent need for effective treatments [8] - The diseases are estimated to affect around 5,000 individuals in the U.S. and up to 8,000 in Europe, indicating a significant market opportunity for EMPAVELI [8]
Apellis Announces 5-Year GALE Data Showing SYFOVRE® (pegcetacoplan injection) Delayed Progression of Geographic Atrophy by ~1.5 Years
Globenewswire· 2025-11-12 12:00
Core Insights - Apellis Pharmaceuticals announced positive long-term data from the GALE extension study, showing that SYFOVRE® significantly delays the progression of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) [1][2][3] Study Results - The analysis revealed that both monthly and every-other-month administration of SYFOVRE delayed GA lesion growth by approximately 1.5 years compared to a projected sham treatment [2][3] - The safety profile of SYFOVRE remained consistent over the five-year period, aligning with previously reported data [3] Study Design - The GALE study is a Phase 3, multicenter, open-label extension study involving 792 patients, aimed at evaluating the long-term efficacy and safety of SYFOVRE in GA patients [5] - More than 80% of participants from the earlier OAKS and DERBY studies transitioned into the GALE study [5] Mechanism of Action - SYFOVRE targets C3 in the complement cascade, providing comprehensive control of the immune response, which is crucial for managing GA [10] Disease Impact - Geographic atrophy is a leading cause of blindness, affecting over one million Americans and five million people globally, with significant implications for patients' quality of life [11]